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S0429: Docetaxel, Cetuximab, ...

S0429: Docetaxel, Cetuximab, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer

Last Updated: 2013-01-04

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2012-04-30

Brief Summary

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RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving docetaxel and cetuximab together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when given together with cetuximab and radiation therapy in treating patients with stage III non-small cell lung cancer.

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Detailed Description

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OBJECTIVES:

Primary

* Test the feasibility and toxicity of combined cetuximab, weekly docetaxel, and concurrent radiotherapy in patients with poor-risk stage III non-small cell lung cancer (NSCLC).

Secondary

* Evaluate response rates (confirmed and unconfirmed, complete and partial) as well as overall and progression-free survival.
* Correlate EGFR mutations, KRAS mutations, EGFR/HER2 gene copy number detected by FISH, and protein expression by immunohistochemistry of EGFR-HER signaling pathways, phosphorylation, proliferative markers, apoptotic markers, selected oncogene markers, and markers for angiogenesis in biopsied pre-treatment tumor tissues with response and survival outcomes.
* Explore possible associations between changes in plasma angiogenic factors (VEGF, IL-8, bFGF) and cytokine levels (IL-6, IL-1α, ICAM, TGF-β, and others) and the risk of treatment-related pneumonitis and esophagitis.

OUTLINE: Patients are enrolled sequentially to 1 of 2 treatment groups.

* Cohort 1: Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22.
* Cohort 2: Patients receive cetuximab as in group 1 followed by docetaxel IV over 15-30 minutes on days 8, 15, and 22 of course 1 and on days 1, 8, 15, and 22 of course 2.

Initially, 27 patients will be enrolled in Cohort 1. Once all patients in Cohort 1 have discontinued treatment, if toxicity rates are acceptable per protocol specifications, an additional 27 patients will be enrolled to Cohort 2. Treatment in both cohorts repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. All patients also undergo radiotherapy once daily, 5 days a week, beginning on day 8 of course 1 and continuing through course 2 (approximately 7 weeks). Patients with no progressive disease then receive cetuximab alone once weekly. Treatment with cetuximab alone continues in the absence of disease progression for up to 2 years.

After completion of study treatment, patients are followed periodically for up to 3 years.

PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.

Conditions

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Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cetuximab + Radiotherapy (no Docetaxel)

Group Type EXPERIMENTAL

cetuximab

Intervention Type BIOLOGICAL

Cohorts 1 and 2: 400 mg/m2 (initial dose) 2 hour IV infusion on Day 1, Cycle 1 only.

250 mg/m2, 1 hour IV infusion on Days 8 , 15 and 22 during Cycle 1. 250 mg/m2 (subsequent doses), 1 hour IV infusion on Days 1, 8 , 15 and 22 during subsequent cycles.

radiation therapy

Intervention Type RADIATION

Radiation therapy should begin on Day 8 of Cycle 1 and continue through the end of Cycle 2. Refer to Section 12.1 for Radiation Therapy Review.

RT prescription should be PTV (GTV + 2-cm margins on CT scan) to 6,480 cGy in 36 fractions given 5 days a week, 180 cGy per day. The dose is prescribed to the isocenter. The entire treatment should be planned prior to starting treatment to ensure that the plan meets protocol specifications.

Cetuximab + Radiotherapy + Docetaxel

Group Type EXPERIMENTAL

cetuximab

Intervention Type BIOLOGICAL

docetaxel

Intervention Type DRUG

Cohort 2 ONLY: 20 mg/m2 IV over 15 - 30 minutes on Days 8, 15 and 22 of Cycle 1. Concurrent with RT and cetuximab starting at Week 2.

20 mg/m2 IV over 15 - 30 minutes on Days 1, 8, 15 and 22 of Cycle 2.

radiation therapy

Intervention Type RADIATION

Interventions

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cetuximab

Intervention Type BIOLOGICAL

docetaxel

Intervention Type DRUG

radiation therapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Histologically or cytologically proven newly diagnosed single, primary, bronchogenic stage IIIA or selected stage IIIB (excluding malignant pleural effusion) non-small cell lung cancer (NSCLC) of one of the following cellular types:

* Adenocarcinoma
* Large cell carcinoma
* Squamous cell carcinoma
* Unspecified
* Histology or cytology from involved mediastinal or supraclavicular nodes will be sufficient for diagnosis if a separate primary lesion of the lung parenchyma is clearly evident on radiographs (i.e., a second biopsy will not be required)
* Underwent positron emission tomography (PET) scan within the past 42 days

* N2 or N3 mediastinal disease by PET scan OR enlarged nodes on CT scan determined to be N2 or N3 by biopsy
* Measurable disease, defined as lesions that can be accurately measured in at least one dimension as ≥ 2 cm by conventional techniques or ≥ 1 cm by spiral CT scan

* Pleural effusion, ascites, bone lesions, and laboratory parameters are not considered measurable disease
* No brain metastases
* Malignant pleural effusion allowed provided 1 of the following is true:

* Present before mediastinoscopy or exploratory thoracotomy AND the pleural fluid is transudate with negative cytology
* Present only after but not before exploratory or staging thoracotomy AND the pleural fluid is either transudate or exudate with negative cytology
* Present only on CT scan but not on decubitus chest x-ray AND deemed too small to tap under either CT scan or ultrasound guidance

PATIENT CHARACTERISTICS:

* Zubrod performance status 0-1, meeting ≥ 1 of the following criteria OR Zubrod performance status 2 with no co-morbidities or meeting 1 of the following criteria:

* No co-morbidities
* FEV\_1 \< 2 L OR \< 1 L with estimated contralateral FEV\_1 ≥ 0.6 L
* DLCO \> 10 mL/mm Hg/min
* Albumin \< 0.85 times lower limit of normal
* Unintentional weight loss \> 10% within the past 6 months
* Controlled congestive heart failure which, in the opinion of the investigator, may become decompensated due to radiotherapy
* FEV\_1 \< 2 L OR \< 1 L with estimated contralateral FEV\_1 ≥ 0.6 L
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
* Must provide prior smoking history
* Serum bilirubin normal
* Meets one of the following criteria:

* Alkaline phosphatase (AP) ≤ 4 times ULN AND SGOT or SGPT normal
* AP normal AND SGOT or SGPT ≤ 2.5 times ULN
* No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or adequately treated stage I or II cancer from which the patient is currently in complete remission
* No pregnant or nursing patients
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy or curative surgery for this cancer
* No prior radiotherapy to the neck and/or thorax for any reason
* No prior therapy which specifically targets the EGFR pathway
* No concurrent growth factors (e.g., filgrastim \[G-CSF\], epoetin alfa, or pegfilgrastim) or amifostine
* No concurrent intensity-modulated radiotherapy
* No concurrent prophylactic mediastinal, contralateral hilar, or supraclavicular lymph node radiotherapy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yuhchyau Chen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

James P. Wilmot Cancer Center

Kishan J. Pandya, MD

Role: PRINCIPAL_INVESTIGATOR

James P. Wilmot Cancer Center

Derick H. Lau, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Karen Kelly, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Laurie E. Gaspar, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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Alaska Regional Hospital Cancer Center

Anchorage, Alaska, United States

Site Status

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States

Site Status

Tibotec Therapeutics - Division of Ortho Biotech Products, LP

Marysville, California, United States

Site Status

University of California Davis Cancer Center

Sacramento, California, United States

Site Status

University of Colorado Cancer Center at UC Health Sciences Center

Aurora, Colorado, United States

Site Status

Veterans Affairs Medical Center - Denver

Denver, Colorado, United States

Site Status

Shaw Regional Cancer Center

Edwards, Colorado, United States

Site Status

Poudre Valley Hospital

Fort Collins, Colorado, United States

Site Status

Valley View Hospital Cancer Center

Glenwood Springs, Colorado, United States

Site Status

Montrose Memorial Hospital Cancer Center

Montrose, Colorado, United States

Site Status

Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - West

Boca Raton, Florida, United States

Site Status

Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus

Boca Raton, Florida, United States

Site Status

Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

Savannah, Georgia, United States

Site Status

Pearlman Comprehensive Cancer Center at South Georgia Medical Center

Valdosta, Georgia, United States

Site Status

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, United States

Site Status

Hematology Oncology Consultants - Naperville

Naperville, Illinois, United States

Site Status

Hospital District Sixth of Harper County

Anthony, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, United States

Site Status

Cancer Center of Kansas, PA - El Dorado

El Dorado, Kansas, United States

Site Status

Cancer Center of Kansas - Fort Scott

Fort Scott, Kansas, United States

Site Status

Cancer Center of Kansas-Independence

Independence, Kansas, United States

Site Status

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, United States

Site Status

Lawrence Memorial Hospital

Lawrence, Kansas, United States

Site Status

Southwest Medical Center

Liberal, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Newton

Newton, Kansas, United States

Site Status

Olathe Cancer Center

Olathe, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Salina

Salina, Kansas, United States

Site Status

Cotton-O'Neil Cancer Center

Topeka, Kansas, United States

Site Status